Download Our MDR Changes Slide Deck

The new medical device regulations will be introduced in May 2021.  The MDR changes will see an increased set of responsibilities for manufacturers, economic operators, authorised representatives, and distributors.  Our MDR regulatory affairs consultants are currently working with companies to help them to prepare for the changes.

We have created a slide deck that takes a brief look at the changes.

In this slide deck we look at:

  • Why there is a need to move from the Medical Devices Directive, first introduced in 1993 to the new medical devices regulations.
  • What are the most notable changes contained in the MDR?
  • We look at the increased role of clinical data in the medical device regulations.  The slide deck looks at issues regarding clinical evaluation reports.
  • And finally, we look at the widening of the definition of what constitutes a medical device.  The MDR brings in products that have previously been regarded as aesthetic and cosmetic products.

You can download the slide deck by completing the form below.

Further MDR reading from Acorn Regulatory

A Guide to Drug-Device Combination Products

We have produced a drug-device guide that looks at the issue.  It also considers the issue in relation to the changes for drug-device combination products in relation to the Medical Device Regulations.  You can download the guide here.

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.

Get The 1st Acorn Regulatory Medical Device Regulations Whitepaper

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here

2nd Acorn Regulatory MDR Whitepaper

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.

The Medical Device Regulations – MDR – What You Need To Know

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.